BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HS II PROXIMAL SEAL SYSTEM 4.3MM

    MDR report key: 2152429 · Received June 24, 2011

    Report

    Report Number
    2242352-2011-00742
    Event Type
    Malfunction
    Date Received
    June 24, 2011
    Date of Event
    May 18, 2011
    Report Date
    June 2, 2011
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    DXC
    PMA / PMN Number
    K080169
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: VISUAL INSPECTION REVEALED THAT THE DELIVERY TUBE WAS RETURNED SEPARATE FROM THE LOADING DEVICE. THE SEAL AND THE TENSION SPRING ASSEMBLY WERE INSIDE THE BODY OF THE LOADING DEVICE. THE GREEN SLIDE LOCK AND THE WHITE PLUNGER WERE DEPRESSED ON THE DELIVERY DEVICE. THERE WAS NO EVIDENCE OF BLOOD ON THE DEVICE. BASED UPON THE RECEIVED CONDITION OF THE DEVICE, THE REPORTED COMPLAINT "SEAL GOT STUCK IN THE DEPLOYMENT DEVICE" WAS CONFIRMED AS A "FAILURE TO LOAD" ISSUE. A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE REPORTED PRODUCT LOT NUMBER. THERE WAS NO NONCONFORMANCE WHICH COULD HAVE CONTRIBUTED TO THIS FAILURE MODE. (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE, THE HEARTSTRING III SEAL GOT STUCK IN THE DEPLOYMENT DEVICE. A REPLACEMENT UNIT WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY PATIENT EFFECTS. THE PRODUCT WAS RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HS II PROXIMAL SEAL SYSTEM 4.3MM PROXIMAL SEAL DXC MAQUET CARDIOVASCULAR, LLC HSK-3043 25032332

    Patients

    Seq Age Sex Outcome Treatment
    1 NA